1.Regulatory policy analysis of pharmacy compounding drug products in the United States and its implications
Haijian LI ; Anqi DENG ; Qing GUO ; Wei LIU
China Pharmacy 2026;37(14):1819-1825
OBJECTIVE To systematically review the key regulatory requirements for pharmacy compounding drug products in the United States, and to provide references for improving the management framework of pharmacy compounding drug products in China, thereby ensuring the safety and accessibility of medication use. METHODS A literature revi ew was conducted to summarize the regulatory requirements and practical characteristics of pharmacy compounding drug products under Section 503A of the United States Federal Food, Drug, and Cosmetic Act . Based on regulatory experience of the United States, current status and existing deficiencies in pharmacy compounding drug products in China were analyzed, and targeted recommendations were proposed. RESULTS &CONCLUSIONS The United States has established a systematic regulatory framework for pharmacy compounding drug products under Section 503A, covering prescription management, active pharmaceutical ingredient management, list management of withdrawn or removed drugs and drugs that present demonstrable difficulties for compounding, recordkeeping management, interstate distribution and so on. Through standardized regulation of the entire compounding process and collaborative governance with expert advisory committees, this framework effectively balances individualized medication needs with drug quality and safety. In contrast, pharmacy compounding drug products in China remain largely confined to traditional Chinese medicine and face several challenges, including the lack of legal and regulatory support, inadequate quality control, lagging development of industry standards, and shortages of specialized personnel. It is recommended that China should establish a tiered regulatory system, develop comprehensive technical standards, build a localized regulatory framework, promote technological innovation, and strengthen professional talent cultivation to better balance the legitimate rights and interests of public medication use with drug safety and efficacy, thereby enhancing public health.
2.Assessing The Contribution of Non-crossover (NCO) to Genetic Diversity From a Complete Recombination Map
Zhi-Hao DU ; Jing CANG ; Guo-Qing LIU
Progress in Biochemistry and Biophysics 2026;53(10):2835-2840
Meiotic recombination is a core molecular event that generates genetic diversity in sexually reproducing organisms, and is of great significance for both genome evolution and proper chromosome segregation. Meiotic recombination occurs in two forms: crossover (CO) and non-crossover (NCO). Although NCO events are far more abundant than CO events, they have been difficult to detect. Consequently, previous research has largely focused on CO, leaving the characteristics and functional roles of NCO poorly understood. A recent study published in Nature used large-scale family-based whole-genome sequencing data to construct a high-resolution recombination map. This map revealed the mutational features induced by NCO—the dominant form of recombination—along with their sex-specific differences, and quantified, for the first time, the contribution of NCOs to de novo mutations and age-related effects, representing an important milestone in the field of meiotic recombination. Specifically, compared with paternal NCOs, maternal NCOs are fewer in number but span longer regions; they accumulate continuously with increasing maternal age and occur largely outside programmed recombination hotspots. NCOs also represent a major source of de novo mutations, with approximately 11% of maternal de novo mutations being attributable to NCOs. This study not only provides a high-resolution map of human meiotic recombination as a resource for future research, but also offers, for the first time, a genome‑wide perspective on the contribution of meiotic NCO recombination to genetic diversity.
3.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
4.Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury (version 2025)
Kai HUANG ; Lunhao BAI ; Qing BI ; Hong CHEN ; Jiwu CHEN ; Xuesong DAI ; Wenyong FEI ; Weili FU ; Zhizeng GAO ; Lin GUO ; Yinghui HUA ; Jingmin HUANG ; Suizhu HUANG ; Xuan HUANG ; Jian LI ; Qiang LI ; Shuzhen LI ; Yanlin LI ; Yunxia LI ; Zhong LI ; Ning LIU ; Yuqiang LIU ; Wei LU ; Hongbin LYU ; Haile PAN ; Xiaoyun PAN ; Chao QI ; Weiliang SHEN ; Luning SUN ; Jin TANG ; Zimin WANG ; Bide WANG ; Ru WANG ; Shaobai WANG ; Licheng WEI ; Weidong XU ; Yongsheng XU ; Jizhou YANG ; Liang YANG ; Rui YANG ; Hongbo YOU ; Tengbo YU ; Jiakuo YU ; Bing YUE ; Hua ZHANG ; Hui ZHANG ; Qingsong ZHANG ; Xintao ZHANG ; Jiajun ZHAO ; Lilian ZHAO ; Qichun ZHAO ; Song ZHAO ; Jiapeng ZHENG ; Jiang ZHENG ; Zhi ZHENG ; Jingbin ZHOU ; Jinzhong ZHAO
Chinese Journal of Trauma 2025;41(4):325-338
With the rapid development of competitive sports, the incidence of anterior cruciate ligament (ACL) injury is on the rise. Such injuries may shorten athletes′ career and lead to other long-term adverse consequences. Although athletes generally recover well after ACL reconstruction, many still struggle to return to their pre-injury performance levels. Advances in the understanding of ACL anatomy and injury mechanisms, along with the evolution of surgical techniques and rehabilitation methods, have provided more individualized and tailored options for athletes following ACL injuries. However, there is currently no consensus in China regarding surgical and rehabilitation strategies for competitive athletes aiming to return to sports after ACL injuries. To this end, the Sports Medicine Committee of the Chinese Research Hospital Association and the Editorial Board of the Chinese Journal of Trauma jointly formulated the Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury ( version 2025), and presented 14 recommendations covering surgical indications, preoperative rehabilitation, surgical timing, surgical strategies and postoperative rehabilitation strategies, aiming to improve the surgical treatment and rehabilitation system for ACL injuries in competitive athletes and facilitate their return to high-level sports performance after injury.
5.Comparison of the prognosis of replanting with cryoinactivation and reconstruction with allogeneic grafts for primary malignant bone tumors of the extremities
Zhuoyu LI ; Daoyang FAN ; Haoyu GUO ; Jilong ZHAO ; Yuan LI ; Qing ZHANG ; Xiaohui NIU ; Weifeng LIU
Chinese Journal of Orthopaedics 2025;45(10):662-669
Objective:To investigate the clinical efficacy of liquid nitrogen cryopreservation and reimplantation versus allograft reconstruction in patients underwent resection of primary malignant bone tumors of the long bones of the extremities.Methods:A retrospective analysis was conducted on 144 patients who underwent resection of primary malignant bone tumors of the long bones of the extremities followed by either liquid nitrogen cryopreservation and reimplantation or massive allografts reconstruction at the Beijing Jishuitan Hospital affiliated with Capital Medical University from January 2012 to July 2023. The study included 82 males and 62 females, with an average age of 23.8±12.3 years (range, 6-64 years). Patients were divided into two groups based on the reconstruction method: the cryopreservation and reimplantation group (72 cases) and the allograft group (72 cases). The following outcomes were recorded during follow-up: local tumor recurrence, bone union, union time, graft survival, and reasons for graft removal. Graft-related complications were recorded using the modified Henderson classification system of the International Limb Salvage Association. Limb function was assessed at the last follow-up using the Musculoskeletal Tumor Society score (MSTS-93).Results:All patients completed surgery and were followed up for a mean of 60.2±32.1 months (range, 12-149 months). At the last follow-up, 24 patients were dead from the tumor, 16 patients survived with the tumor (2 cases of local recurrence and 14 cases of distant metastasis), and 104 patients survived without the tumor. The bone union rate and union time in cryopreservation and reimplantation group were 90% (65/72) and 9.6±4.8 months, respectively, which was significantly superior to those in allograft group [68% (49/72) and 15.9±6.7 months, P<0.05]. The 5-year overall graft survival rate was 86.8% [95% CI (80.1%, 95.7%)] in cryopreservation and reimplantation group, higher than 73.2% [95% CI(68.4%, 84.5%)] in allograft group significantly (χ 2=7.122, P=0.017). The rates of graft removal due to non-union and infection in the cryopreservation and reimplantation group were 0% (0/72) and 1.4% (1/72), respectively, which were significantly lower than those in the allograft group [5.6% (4/72) and 9.7% (7/72), P<0.05]. Overall, 48.6% (70/144) of patients experienced at least one graft-related complication, with a complication rate of 33.3% in cryopreservation and reimplantation group, lower than the 61.1% in allograft group significantly (χ 2=11.146, P<0.001). The complications with the highest incidence rate were nonunion (20.8%, 30/144), followed by structural failure (17.4%, 25/144), tumor progression (10.4%, 15/144), infection (10.4%, 15/144), and soft tissue failure (5.6%, 8/144). The incidence rates of the atrophic non-union and the structural failure of grafts were 9.7% (7/72) and 1.4% (1/72) respectively in the cryopreservation and reimplantation group, which were significantly lower compared to the allograft group [29.2% (21/72) and 13.9% (10/72), P<0.05]. At the last follow-up, the MSTS-93 score was 89.7%±8.3% in the cryopreservation and reimplantation group, and 87.6%±7.5% in the allograft group, with no statistically significant difference ( t=0.326, P=0.542). Conclusion:Compared with allograft reconstruction, autologous inactivated bone grafting demonstrated superior bone union efficiency and fewer complications, it may be considered for reconstruction in cases whose tumor bone is not severely osteolytic or pathologically fractured.
6.Analysis on Screening Results of Breast Cancer Among Women Aged 45~74 in Chongqing from 2012 to 2022
Jia DU ; Zhikai YU ; Shenglin ZHAO ; Yan ZHANG ; Qing GUO ; Xiu LIU ; Hong ZHOU ; Mei HE
China Cancer 2025;34(1):43-51
[Purpose]To analyze the results of breast cancer screening among women aged 45~74 in Chongqing from 2012 to 2022 and compare the risk of breast cancer among women with differ-ent characteristics.[Methods]The Urban Cancer Early Diagnosis and Treatment Program was con-ducted in Chongqing from 2012 to 2022,female residents aged 45~74 years old participated in breast cancer screening.The participants who were assessed as at high risk of breast cancer in the preliminary screening were advised to receive ultrasonography and mammography examination in designated hospitals.The study population was followed up annually to obtain information on their health outcomes.The high risk rate of breast cancer,compliance of further examination,the inci-dence density and breast cancer risk were calculated.[Results]A total of 207 891 women com-pleted the questionnaires survey and risk assessment,and 35 947 were assessed as the individuals with high risk of breast cancer with a high risk rate of 17.29%.Among them 14 713 received the imaging screening with a compliance rate of 40.93%.After a mean follow-up of(5.43±3.01)years,847 cases of breast cancer were diagnosed with a cumulative incidence rate of 407.43/105,an in-cidence density of 75.03/105 person-years(95%CI:70.15/105~80.26/105 person-years).Cox pro-portional hazards regression showed that the risk of breast cancer was higher in obese women than that in normal weight women(HR=1.26,95%CI:1.00~1.59);the risk of breast cancer was signifi-cantly higher in those with family history of breast cancer than that in those without family history(HR=1.69,95%CI:1.36~2.09).Compared with non-high-risk groups of breast cancer,the risk of breast cancer was increased in high-risk individuals who were screened or not screened(HR=1.36,95%CI:1.06~1.73 and HR=1.26,95%CI:1.01~1.56).[Conclusion]The breast cancer screening program combining primary risk assessment with ultrasonography and mammography for the high-risk groups can improve the detection rate,and the compliance rate of imaging screening need to be improved in the future and make accurate screening for people with high risk of breast cancer.
7.Efficacy of nucleos(t)ide analogues combined with peginterferon α-2b on antiviral therapy in children with chronic hepatitis B
Wenting CHEN ; Shilian LI ; Xiaochen MA ; Fang CHEN ; Lijian RAN ; Yi WU ; Yan GUO ; Yan ZHU ; Qing MAO ; Huimin LIU
Chinese Journal of Experimental and Clinical Virology 2025;39(4):411-418
Objective:To analyze the efficacy of combination of peginterferon α-2b(Peg-IFN α-2b)with nucleos(t)ide analogues(NAs)on antiviral therapy in children with chronic hepatitis B(CHB)and to provide an optimized clinical treatment strategies for CHB children.Methods:A retrospective analysis was conducted on 30 CHB children treated in The First Affiliated Hospital of the Army Medical University(Southwest Hospital)from January 2022 to January 2025 with treatment duration at least 48 weeks. The enrolled children were aged between 2 and 17 years and divided into the NAs combined with Peg-IFN α-2b(NPI)group(n=13)and NAs group(n=17)by their therapy regimens. The characteristics of baseline,week 12,week 24,week 48 and week 96 were compared between groups,as well as the differences in response to biochemical,immune and viral indicators at each observation point. Logistic regression analysis and receiver operating characteristic(ROC)curve analysis were performed to identify factors influencing the HBsAg seroclearance. Results:At baseline of treatment,the proportion of HBeAg positivity in the NPI group and the NAs group was high(76.9% vs 86.6%, χ2=0.679, P=0.628),and the alanine aminotransferase(ALT)and aspartate aminotransferase(AST)in the NPI group were significantly lower than those in the NAs group( P<0.001). At 24 weeks,the decrease in HBsAg in the NPI group was also significantly higher than that in the NAs group( Z=-3.161, P=0.002). Finally,the cumulative seroclearance rate of HBsAg at 96 weeks in the NPI group was significantly higher than that in the NAs group(46.15% vs 5.88%, χ2=0.679, P=0.025). Mulitivariate Logistic regression analysis showed that treatment regimen and gender were risk factors affecting the outcome of HBsAg( P<0.05). ROC curve analysis showed that the increase in ALT at 12 weeks compared with baseline(AUC=0.857,Cutoff value=3.615 IU/L),the decrease in ALT at 24 weeks(AUC=0.870,Cutoff value=47.85 IU/L),and the decrease in HBsAg at 12 weeks and especially at 24 weeks(AUC=0.885,Cutoff value=0.97log IU/ml)were effective predictors of HBsAg prognosis at 96 weeks. Conclusion:In CHB children,antiviral regimen Peg-IFN α-2b combined with NAs was more effective than NAs alone in improving the HBsAg seroclearance rate of CHB,and the effects in female were better than in male. The decline of HBsAg and the fluctuation of ALT in the early treatment period are valid predictors of HBsAg clearance.
8.Risk factors for in-hospital mortality in patients with acute myocardial infarction undergoing emergency percutaneous coronary intervention
Anheng LIU ; Qing GUO ; Xupeng BAI ; Lijun LI ; Jianping LUO
Military Medical Sciences 2025;49(2):114-118
Objective To study the risk factors for in-hospital mortality in patients with acute myocardial infarction(AMI)undergoing emergency percutaneous coronary intervention(EPCI).Methods Nine hundred and eight patients with acute myocardial infarction(AMI)who underwent EPCI at Beijing Jingmei Group General Hospital between September 2016 and December 2022 were enrolled and divided into an in-hospital death group(36 cases)and a survival group(872 cases)based on in-hospital outcomes.The basic information,clinical indicators,results of coronary angiography,outcomes of EPCI,and complications were compared between the two groups.Multiple logistic regression analysis was conducted to identify the risk factors for in-hospital mortality during EPCI.Results The age and serum creatinine levels of the death group were higher than those of the survival group(P<0.05),and the estimated glomerular filtration rate(eGFR)and hemoglobin(Hb)levels were lower than those of the survival group(P<0.05).The proportion of diabetes mellitus,cerebral infarction,cardiogenic shock,left main culprit lesion,rapid ventricular arrhythmia,TIMI flow grade<3 after EPCI for culprit vessel,and intra-aortic balloon pump(IABP)implantation in the death group were higher than those of the survival group(P<0.05).The results of multiple logistic regression analysis showed that age,cardiogenic shock,TIMI flow grade<3 after culprit vessel intervention,and rapid ventricular arrhythmia had a statistically significant impact on in-hospital mortality in EPCI(P<0.05).Conclusion Age,cardiogenic shock,TIMI flow grade<3 after PCI for culprit vessels,and rapid ventricular arrhythmia are independent risk factors for in-hospital mortality in EPCI patients with AMI.
9.Structural equation analysis and modeling of fect and ankles WMSDs and its adverse ergonomic factors
Xi ZHANG ; Ning JIA ; Xin SUN ; Meibian ZHANG ; Qing XU ; Huadong ZHANG ; Ruijie LING ; Yimin LIU ; Gang LI ; Yan YIN ; Hua SHAO ; Hengdong ZHANG ; Yanmin QI ; Bing QIU ; Tiebing LIU ; Dayu WANG ; Qiang ZENG ; Yan YE ; Bin XIAO ; Hua ZOU ; Jianchao CHEN ; Dongxia LI ; Yongquan LIU ; Jixiang LIU ; Enfei JIANG ; Jun QI ; Liangying MEI ; Tianlai LI ; Mimi YANG ; Xinwei GUO ; Zhongxu WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(2):101-109
Objective:To explore the structural equation model to explore the levels of work-related musculoskeletal disorders (WMSDs) and various risk factors in the feet and ankle of China's occupational population, providing scientific basis for for preventing WMSDs in feet and ankles.Methods:Data of 73497 national occupational epidemiological cases were selected from June 2018 to December 2023 used the Chinese version of the Electronic Questionnaire on Musculoskeletal Disorders. The adverse ergonomic factors and their source classification standard and confirmatory factor analysis were used to investigate foot and ankle WMSDs and their related risk factors (including individual factors, work organization, work posture, work type, fatigue, etc.) in key occupational groups in China, and structural equation model hypothesis, fitting, verification, and path and intermediary effect analysis were carried out. The model fit evaluation indexes included Chi-square specific degrees of freedom ( χ2/ df), gauge fit index (NFI), Tucker Lewis index (TLI), goodness of Fit index (GFI), adjusted Goodness of Fit index (AGFI) and approximate root mean square error (RMSEA) . Results:A total of 73497 occupational workers were surveyed, with local muscle fatigue and WMSDs incidence rates in the feet and ankles being 17.17% and 12.06%, respectively. The fitting index of the adjusted structural equation model basically meets the standard (GFI=1, AGFI=1, RMESA=0.042, NFI=0.716, TLI=0.663). The top three factors affecting feet and ankle WMSDs are feet and ankle muscle fatigue, work type, and work organization, with standardized path coefficients of 0.221, 0.105, and 0.095, respectively. The top two factors affecting feet and ankle muscle fatigue are work organization and work type, with standardized path coefficients of 0.548 and 0.383, respectively. Feet and ankle muscle fatigue, work type, work organization, and work posture have a direct effect on feet and ankle WMSDs, with effect values of 0.221, 0.105, 0.095, and 0.077, respectively. The organization and type of work can also have indirect effects through feet and ankle muscle fatigue, with effect values of 0.121 and 0.084, respectively.Conclusion:Feet and ankle muscle fatigue has a direct impact on WMSDs, and plays a mediating role between ankle and ankle WMSDs caused by work organization and work type. Feet and ankle muscle fatigue is an important pathway leading to feet and ankle WMSDs. It is recommended that employers and managers detect job fatigue early and take corresponding prevention and intervention measures, which can play a key role in preventing feet and ankle WMSDs.
10.Structural equation analysis and modeling of upper limb WMSDs and their adverse ergonomic factors
Siwu ZHONG ; Ning JIA ; Xin SUN ; Meibian ZHANG ; Qing XU ; Huadong ZHANG ; Ruijie LING ; Yimin LIU ; Gang LI ; Yan YIN ; Hua SHAO ; Jue LI ; Hengdong ZHANG ; Bing QIU ; Dayu WANG ; Qiang ZENG ; Rugang WANG ; Yan YE ; Bin XIAO ; Hua ZOU ; Jianchao CHEN ; Dongxia LI ; Yongquan LIU ; Qinghua SHI ; Jixiang LIU ; Enfei JIANG ; Jun QI ; Liangying MEI ; Xianfeng ZHAO ; Mimi YANG ; Xinwei GUO ; Zhi WANG ; Zhongxu WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(4):254-263
Objective:To explore the structural relationship between WMSDs in the upper limbs and various risk factors in the occupational population in China, based on a large sample epidemiological survey and structural equation analysis, and to establish a structural equation model, so as to lay a foundation for the prevention and control of such diseases.Methods:The Chinese version of the Musculoskeletal Disorders Electronic Questionnaire was used to conduct a nationwide survey on the prevalence of WMSDs in the upper extremity. Six factors related to WMSDs in the upper extremity were extracted by the classification standard of adverse ergonomic factors and their source and confirmatory factor analysis, including work organization, work type, upper extremity work posture, individual factors, upper extremity fatigue and upper extremity WMSDs. The structural equation analysis was carried out and the structural equation model was established.Results:The incidence of WMSDs and fatigue in the upper limbs was 24.44% and 43.76%, respectively. The adjusted structural equation model fitting indicators were generally up to the standard (GFI=1.000, AGFI=1.000, RMSEA=0.043, NFI=0.808, TLI=0.784) . The four exogenous latent variables of work organization, work type, upper limb work posture and individual factors were correlated. There was a strong positive correlation between job type and upper limb work posture ( r=0.865) , a moderate positive correlation between work organization and job type and upper limb work posture ( r=0.570, 0.490) , and a weak negative correlation between individual factors and the other three exogenous latent variables. Upper limb work posture and individual factors had direct effects on upper limb WMSDs, and the effect coefficients were 0.10 and 0.06, respectively. Upper limb fatigue played a mediating role between work organization, work type, upper limb work posture and upper limb WMSDs. The effect coefficient was 0.46, and the composition ratios of indirect effects were 100.0%, 100.0%, and 38.3%, respectively. The direct path effect of upper limb work posture, individual factors and upper limb WMSDs was weaker than the mediating path through upper limb fatigue. Conclusion:When carrying out the prevention and control of upper limbWMSDs, it is necessary to comprehensively consider the pathogenesis path of upper limb muscle fatigue and upper limb WMSDs caused by work organization, work type, and upper limb work posture, so as to provide theoretical reference for improving the prevention and control level of such diseases.

Result Analysis
Print
Save
E-mail